NCT00400127终止不适用
The Effect of Silicone Suspension on Standing Balance for Transfemoral Amputees
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Quiet standing balance
研究概览
简要总结
The objective of this study is to test the hypothesis that silicone suction suspension without additional belt support does not significantly diminish the postural sway or walking performance of persons with transfemoral amputation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •be forty-five (45) or older;
- •unilateral transfemoral amputee;
- •current patients of the QEII Health Sciences Centre Amputee Service based at the Rehab Site;
- •can walk comfortably with their prosthesis for a minimum of 5 minutes, regardless of whether they require ambulation aids (i.e. canes, walkers, etc.);
- •are in the process of being fitted with a silicon suction liner and pin system;
- •are competent to give informed consent or have a proxy with power of attorney;
- •have the written permission of the attending physician to participate;
- •be willing to take part in the study, including signing the consent after carefully reading it.
排除标准
- •have an unstable medical condition (e.g. angina, seizures), as determined by the attending or house physician;
- •have major medical or neurological conditions that affect balance (specifically Parkinson's disease, stroke or Multiple Sclerosis), as determined by the physician or house staff physician;
- •have an emotional or psychiatric problem of a type or extent that might make participation unpleasant, as determined by the attending or house physician.
结局指标
主要结局
Quiet standing balance
Timed-up and Go
ambulation profile
questionnaire
次要结局
- demographics
- prosthetic components
研究者
研究点 (2)
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